JR/Med Qualification
hace 4 días
QbD Groupteam offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. We are always looking for the next QbD’er in Qualification & Validation.
What do we expect from you as a Qualification & Validation Specialist ?As a Qualification & Validation specialist, you will work on multiple projects in the Netherlands within several organizations in the pharmaceutical or medical device related industry . You are responsible for effective and efficient validation and qualification of laboratory equipment, cleanrooms, utilities, HVAC systems, GMP production equipment, medical devices and processes.
Main Responsibilities:
- Provide quality and validation oversight to ensure that validation, qualification and other life cycle activities are consistent with company validation policies, procedures and federal regulations;
- Support process validations (IQ/OQ/PQ) and test method validation;
- Identify critical areas for improvement and prioritize and execute the initiatives;
- Perform or support nonconformance / CAPA root cause investigations, defining action plans and driving these to completion;
- Proceed according to the company's quality policy in all business activities;
- Provide advice to improve the quality policies and validation procedures;
- Provide coaching, training and guidance on validations;
- Implement controls to ensure data integrity and traceability of Quality records;
- Act as a subject matter expert during internal and external audits (e.g. FDA).
- You have an academic background related to areas such as pharmacy, chemistry, biology, engineering and related fields;
- You have at least 4 years of experience in qualifications/validations within validation departments in the pharmaceutical sector, medical devices, biotechnology;
- You have experience in qualification/validation documentation management: VP, URS, IQ, OQ, PQ;
- You have experience in complete processes of validations: protocols and validation reports;
- Nice to have experience with SCADA Qualifications;
- You have an advanced level of English: you should be able to write technical documentation in English. Spoken English will also be an advantage as you will be joining a multinational company;
- You have user-level computer skills: word processing, spreadsheet and database;
- You have a strong ability to self-manage and love working in a team. Rigour and proactivity are highly desirable;
- You have excellent communication skills;
- You are an autonomous person with the ability to adapt;
- You are able to adapt to high quality standards, data integrity, GMP.
A true QbD’er can be recognized by the following qualities:
- Resilient : Your strong and positive attitude helps you overcome any challenge;
- Hungry for knowledge: You are always open to learning;
- No non-sense mentality: you can be straightforward in a respectful way;
- Innovative : You are constantly looking for new and better solutions;
- (Not too) serious: your job is serious, but you don’t take yourself too serious.
- QbD Group offers you an attractive and competitive salary package , that will be tailored to individual needs, considering legal requirements and local laws and regulations;
- Join us to build a sustainable career , where job security is ensured, and lasting, meaningful connections are formed;
- As we’re a knowledge-based company , you’re guaranteed to embark on a continuous journey of learning and development;
- Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together.
Our promise to you:
- As an ambitious and pioneering company , we want to offer you the best possible environment to thrive within the life sciences;
- Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals;
- In short … We stand for? JPEG : J oy in P artnership, going for the E xtra mile to G et things done
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family
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